(100 days)
Not Found
No
The summary describes a rigid gas permeable contact lens made of a specific material and tint. There is no mention of any computational or algorithmic components, let alone AI or ML. The performance studies focus on material properties and clinical safety/efficacy compared to a predicate device.
Yes.
The device is indicated for managing irregular corneal conditions and for orthokeratology, which involves treating refractive errors.
No
Explanation: The device is a contact lens used for vision correction and management of corneal conditions, not for diagnosing diseases.
No
The device description clearly states it is a "Rigid Gas Permeable Contact Lens material" and describes its physical composition and tints, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a contact lens for correcting refractive errors and managing irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the material and composition of a contact lens, which is consistent with a medical device for vision correction.
- Performance Studies: The performance studies focus on the safety and efficacy of the contact lens in terms of vision correction and patient comfort. They do not involve analyzing samples from the human body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This contact lens does not perform such a function.
N/A
Intended Use / Indications for Use
The BOSTON XO2 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.
The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The lens is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Product codes (comma separated list FDA assigned to the subject device)
HQD, MUW
Device Description
BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lens material is a fluoro silicone acrylate copolymer rigid gas permeable contact lens material. The material is available in blue, ice blue, green, or violet, yellow and red tint. The lenses may contain an ultraviolet light absorber, Uvinul D-49 or MHB. The blue and ice blue tinted lenses contain the color additive D&C Green No. 6; the green tinted lenses contain the color additives D&C Green No. 6 and C.I. Solvent Yellow No. 18; the violet tinted lenses contain the color additive D&C Violet No. 2. the red tinted lenses contain the color additive D&C Red No. 17; and the yellow lenses contain the color additive C.I. Solvent Yellow No.18. All of those color additives are listed in the Code of Federal Regulations (21 CFR 74.3206).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of non-clinical laboratory testing and clinical testing was performed to demonstrate the safety and effectiveness of the BOSTON XO2 contact lens material.
- Non-clinical testing included:
- Lens Compatibility/Cycling Study: Assessed compatibility with several GP contact lens care regimens. No significant changes to lens parameters after 30 complete cycles.
- Determination of Total Extractables Substances (ISO 10340:1995(E)): Total extractables from BOSTON XO2 were less than from the predicate device (BOSTON XO).
- Determination of Extractable Color Additives and UV Blockers in Boston XO2 Material (ISO 10340:1995(E)): Results similar to those obtained from the predicate device (Boston XO).
- Cytotoxicity Study Using The ISO Agar Overlay Method (ISO 10993-5): Material did not induce cytotoxicity.
- ISO Ocular Irritation Study (ISO 10993-10): Material considered a nonirritant.
- USP and ISO Systemic Toxicity Test (ISO 10993-11): All observations of mice were normal; test samples met requirements.
- Bioburden of Lenses and Stability of Bioburden of Lenses Over time: Evaluation of the BOSTON XO2 material (ISO 11987:1997): Average bioburden levels after 30 days were within acceptable limits (
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
510(K) SUMMARY BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lenses for Daily Wear
AUG 15 2007
1. Applicant's Name and Address
Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609
Debra Ketchum 2. Contact Person Manager, Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-8638 debra.ketchum@bausch.com
ર્જ ldentification of Device
| Common Name: | contact lens-rigid gas permeable (hydrophobic) |
|---|---|
| Trade Name: | Boston XO2 (hexafocon B) Daily Wear Contact |
| Lens | |
| Classification: | Class II ophthalmic (21CFR 886.5916) |
| Device classification: | Class II (21 CFR 886.5916) |
| Product Codes: | HQD, MUW |
Predicate Devices:
The predicate device, Boston XO (hexafocon A) was selected to address material use and design (aspheric, bifocal, toric, irregular corneas, and orthkeratology).
The BOSTON XO2 is substantially equivalent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 2006, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between the two devices is a change in the component ratios.
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| K000795, K001960, K043124 and K011945: Boston XO (hexafocon A) | ||
|---|---|---|
| 510(k) | Clearance Date | Device Description |
| K000795 | 5/26/2000 | Boston XO RGP Daily |
| Wear Contact Lenses | ||
| K001960 | 8/28/2000 | Boston XO RGP for Daily |
| Wear Orthokeratology | ||
| Contact Lenses | ||
| K053124 | 1/30/2006 | Boston XO, Boston EO, |
| Boston ES RGP Daily | ||
| Wear Contact Lenses | ||
| (Post Surgical) | ||
| K011945 | 9/12/2001 | Boston RGP Contact |
| Lenses wet shipped and | ||
| stored in Boston Advance | ||
| Comfort Formula | ||
| Conditioning Solution up | ||
| to 30 days. |
Description of device 4.
BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lens material is a fluoro silicone acrylate copolymer rigid gas permeable contact lens material. The material is available in blue, ice blue, green, or violet, yellow and red tint. The lenses may contain an ultraviolet light absorber, Uvinul D-49 or MHB. The blue and ice blue tinted lenses contain the color additive D&C Green No. 6; the green tinted lenses contain the color additives D&C Green No. 6 and C.I. Solvent Yellow No. 18; the violet tinted lenses contain the color additive D&C Violet No. 2. the red tinted lenses contain the color additive D&C Red No. 17; and the yellow lenses contain the color additive C.I. Solvent Yellow No.18. All of those color additives are listed in the Code of Federal Regulations (21 CFR 74.3206).
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5. Intended use
BOSTON XO2 (hexafocon B) Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eves.
BOSTON XO2 may be prescribed in otherwise non-diseased eves that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
BOSTON XO2 is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
6. Description of Safety and Substantial Equivalence
A series of non-clinical laboratory testing and clinical testing was performed to demonstrate the safety and effectiveness of the BOSTON XO2 contact lens material. A summary of results from the non-clinical and clinical tests is provided below.
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6.1. Lens Compatibility/Cycling Study
The compatibility of BOSTON XO2 material with several GP contact lens care regimens was assessed in this study. A lens cvcling study was completed with each contact lens care regimen. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles. -
6.2. Determination of Total Extractables Substances (ISO 10340:1995(E))
Total Extractables testing was conducted on three lots of BOSTON XO2. The total amount of material extracted from BOSTON XO2 was less than that extracted from BOSTON XO the predicate device. -
6.3. Determination of Extractable Color Additives and UV Blockers in Boston XO2 Material (ISO 10340:1995(E))
Determination of Extractable color additives and UV blockers testing was conducted on Boston XO2 material. These results are similar to those obtained when extracting Boston XO, the predicate device.
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6.4. Cytotoxicity Study Using The ISO Agar Overlay Method (ISO 10993-5)
This in-vitro assay demonstrated the biocompatibility of this material. The test sample is placed on an agar surface directly overlaying a arowing L-929 cell monolayer to determine if the material induces a cvtopathic effect. The material did not induce cytotoxicity. -
6.5. ISO Ocular Irritation Study (ISO 10993-10)
USP 0.9% Sodium Chloride Injection and sesame oil extracts of the Boston XO2 GP lens material was evaluated for the potential to produce an irritating effect on the ocular tissue of the rabbits. According to the criteria of the study protocol, the material is considered to be a nonirritant. -
6.6. USP and ISO Systemic Toxicity Test (ISO 10993-11)
This study was designed to evaluate acute systemic toxicity of the BOSTON XO2 material extract following a single intravenous or intraperitoneal injection into mice. All observations of the mice were normal. The test samples meet the test requirements. -
6.7. Bioburden of Lenses and Stability of Bioburden of Lenses Over time: Evaluation of the BOSTON XO2 material (ISO 11987:1997)
A 30-day shelf-life study for Boston XO2 lenses stored in Boston Advance Comfort Formula Conditioning Solution and Boston SIMPLUS Multi-Action solution was conducted. The average bioburden levels for BOSTON XO2 lenses stored in lens cases with Boston SIMPLUS Multi-Action Solution and Boston Advance Comfort Formula Conditioning Solution after 30 days were within the acceptable bioburden limit of